BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3810767 · Received March 21, 2014

    Report

    Report Number
    8020893-2014-00656
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Report Date
    February 19, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS CURRENTLY BEING INVESTIGATED. AS ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE ISSUED. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA INDICATED THAT AN 840 VENTILATOR EXPERIENCED A DIGITAL GROUND FAILURE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THIS TIME. THE DATE OF THE EVENT IS UNKNOWN. AS ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169678 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1